A Phase 2 interventional study of Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine and High dose Recombinant Trivalent Subunit Rotavirus Vaccine in Rotavirus Infections and Rotavirus Gastroenteritis, sponsored by MAXVAX Biotechnology Limited Liability Company. Active, not recruiting at 2 sites in China. Open to participants aged 6 Weeks to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by MAXVAX Biotechnology Limited Liability Company · Phase 2, Interventional, and Prevention
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
This clinical trial is aimed to evaluate the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in Chinese healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.The subjects will be divided into 12 subgroups. Two different immune regimens and two dose levels will be evaluated in each age group. Toddlers aged 7-71 months will receive two intramuscular injections on Day 0 and 28 or three intramuscular injections on Day 0, 28 and 56. Infants aged 6-12 weeks will receive three intramuscular injections on Day 0, 28 and 56 or Day 0, 56 and 112. Two dose (mid dose and high dose) will be included in each age group. To maintain blindness in the trial, in each age group with fixed immune regimen, subjects will be randomized in a 1:1:1 ratio to receive mid dose vaccine, high dose vaccine, or placebo.
104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 1,512 is above the median of 403 across 69 interventional studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →MAXVAX Biotechnology Limited Liability Company is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
First dose exclusion criteria:
According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Subsequent vaccination exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
Placebo in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.
Biological: Placebo
Placebo in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.
Biological: Placebo
Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine
Placebo in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.
Biological: Placebo
Placebo in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.
Biological: Placebo
0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.
The incidence of adverse events
Incidence of adverse events within 30 minutes after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 30 minutes after each vaccination
The incidence of adverse events
Incidence of adverse events within 14 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 14 days after each vaccination
The incidence of adverse events
Incidence of adverse events Day 15 to 28/30 after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Day 15 to 28/30 after each vaccination
The incidence of adverse events
Incidence of adverse events within 28/30 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 28/30 days after each vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)
Measured by ELISA at baseline and 30 days after the last vaccination.
Time frame: Day 30 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG)
Measured by ELISA at baseline and 30 days after the last vaccination.
Time frame: Day 30 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test at baseline and 30 days after the last vaccination.
Time frame: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Time frame: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Time frame: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Time frame: Day 30 after the last vaccination
Incidence of serious adverse events (SAE)
Incidence of serious adverse events throughout the study.
Time frame: From the first vaccination to 12 months after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Time frame: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Time frame: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Time frame: Day 360 after the last vaccination
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Apr 2023, 3 months.
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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MAXVAX Biotechnology Limited Liability Company